1. Field of the Invention
The present invention relates to an apparatus and method for positioning surgical implants adjacent to body tissue to facilitate the fastening of the implant to the body tissue. More particularly, this invention relates to a cleat adapted for securing a surgical implant to a delivery device and for positioning the implant adjacent to body tissue.
2. Description of the Related Art
Hernias are abnormal protrusions of an organ or other body structure through a defect or natural opening in a covering membrane, muscle or bone. An inguinal hernia is a protrusion which makes its way through the abdomen in the inguinal (groin) region. Hernias may be divided into three general classes: direct inguinal hernia, indirect inguinal hernia and femoral hernia. In both a direct and indirect inguinal hernias, a part of the intestine may protrude through a defect (opening or tear) in the supporting abdominal wall to form a hernial sac. In a femoral hernia, a portion of the intestine is forced through the femoral ring into the femoral canal forming a hernial sac.
Hernia repair typically requires surgery which generally includes an incision in the groin ranging up to six inches in length. Several layers of the abdominal wall are generally separated to reach the herniated portions. During the procedure, the opening or tear in the abdominal wall is closed in a manner which resembles the tying of a sack at the neck. Often a surgical mesh is attached by sutures directly over the repaired hernia opening to provide a reinforcement to the opening.
Traditionally, such hernia repairs involved major invasive surgical procedures which often caused excessive trauma to the patient and necessitated unusually long post-operative recuperative periods. In addition, numerous complications, related directly or indirectly to the surgery often resulted, including bleeding, infection, testicular atrophy, organ damage, nerve damage, blood vessel damage, etc. Further, cutting through the numerous layers of tissue to obtain access to the herniated area often caused severe trauma to the patient. A detailed discussion of traditional hernia repair may be found in "Hernia Repair Without Disability, Second Edition", by Irving L. Lichtenstein. Such invasive surgical procedures have also been utilized in other areas of the body, including surgery on the gall bladder, appendix, lungs and the like.
To avoid many of the previously stated risks and problems, the use of laparoscopic and endoscopic surgical procedures have been relatively popular and has provided additional incentive to develop the procedures further. In laparoscopic procedures, surgery is performed in the interior of the abdomen through a small incision. Similarly, in endoscopic procedures, surgery is performed in any hollow viscus of the body through narrow endoscopic tubes inserted through small entrance wounds in the skin.
Laparoscopic and endoscopic procedures generally require that the surgical region be insufflated. Accordingly, any instrumentation inserted into the body must be sealed to ensure that gases do not enter or exit the body through the incision. Moreover, laparoscopic and endoscopic procedures often require the surgeon to act on organs, tissues and/or vessels far removed from the incision. Thus, instruments used in such procedures are typically long and narrow while being functionally controllable from a proximal end of the instrument.
In hernia surgery, as compared to gall bladder surgery, certain procedures and instruments are the same, and certain instrument requirements differ. For example, in hernia surgery a suitable mesh material is generally sutured over the opening in the tissue. Often, the mesh material is attached by sutures and left within the body to act as a reinforcing agent for tissue regrowth in the area of the surgery. One example of a mesh material currently utilized in hernia surgery includes a polypropylene material marketed by C. R. Bard, under the trademark MARLEX. Another example of a mesh material is a tri-fluoroethylene material marketed by W. L. Gore & Associates, Newark, Del., under the trademark GORE-TEX.
As noted, during conventional invasive surgical procedures, such mesh materials are manually placed over the defect in the abdominal wall and are often sutured within the surgical opening by conventional suturing techniques. However, with the advent of laparoscopic surgery the need for suitable mesh, mesh positioning and mesh attachment techniques through the relatively narrow endoscopic tubes or cannulas is clearly defined. Up to the present, such devices and techniques for mesh positioning have not yet been developed.
Heretofore, resilient umbrella type devices or extractors have been provided to remove objects from body tissue. Exemplary of these devices is U.S. Pat. No. 4,557,255 to Goodman. Goodman discloses a purse-like surgical net which is operable for retrieving stones and the like from within the human body.
U.S. Pat. No. 4,190,042 to Sinnreich discloses a resilient surgical retractor which in an unstressed condition forms a hook-like appendage at the distal end of the retractor.
U.S. Pat. No. 4,586,502 to Bedi et al. discloses a surgical instrument for implanting an "H"-shaped fastener in body tissue and a method of applying fasteners to skin or other tissue in a surgical procedure as an alternative to suturing a wound or surgical incision.
However, there remains a need for an apparatus which facilitates the securing of surgical implants for endoscopic positioning of the implant adjacent to body tissue. In addition to the above apparatus, the present invention relates to a method for positioning surgical implants adjacent to body tissue for stapling.